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A Randomized Study Comparing Xylitol Gummies and Commercial Gummies on Oral Health in Children

EVALUATION OF A XYLITOL-ENRICHED REMINERALIZING GUMMY AND A COMMERCIALLY AVAILABLE GUMMY ON ORAL HEALTH PARAMETERS IN CHILDREN: A RANDOMIZED COMPARATIVE CLINICAL STUDY. - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/104025
Enrollment
40
Registered
2026-02-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K029- Dental caries, unspecified

Interventions

Intervention1: XYLITOL-ENRICHED REMINERALIZING GUMMY: Children in the intervention group will receive gummies containing xylitol and remineralizing agents. The participants will be instructed to consu

Sponsors

Dr Shreya Pokiya
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 8-12 years. Child with dmft index more than 1 Absence of significant systemic health comorbidities. No report of use of antibiotics 3 months before the beginning of the study Demonstrable cognitive capacity to comprehend and adhere to study protocols. Provision of informed consent by parents or legal guardians. Commitment to attending follow-up appointments and assessments as required.

Exclusion criteria

Exclusion criteria: Child within the age below 8 years and above 12 years. Non-compliance with study protocols or procedures. Presence of syndromes impacting dental development or oral health. Systemic diseases that may affect dental treatment outcomes. (e.g., diabetes, cancer, cardiovascular disease Patient undergoing orthodontic treatment. Patient on long term antibiotic Patient with localized pain (e.g., localized abscess, localized infection)

Design outcomes

Primary

MeasureTime frame
1.To evaluate and compare the effect of gummies containing remineralizing agents and xylitol, and other commercially available gummy on salivary ph and buffer capacity using Ph meter. 2.To assess and compare the influence of both interventions on plaque index by Sillness and loe index 1964. 3.To determine and compare the changes in salivary Streptococcus mutans levels following the use of gummies with remineralizing agents and xylitol, and other commercially available gummy using Mitis Salivarius Bacitracin agar Timepoint: Baseline (Day 0): Record all parameters Post-intervention (Immediately): Record all parameters Post-intervention (Day 21): Record all parameters again and compare Post-intervention (Day 60): Record all parameters again and compare Post-intervention (Day 90): Record all parameters again and compare

Secondary

MeasureTime frame
Change in salivary calcium levels following the use of xylitol-enriched remineralizing gummies & commercially available gummies. Change in salivary phosphate levels after intervention in both study groups. Sustained effect of the intervention over time on oral health parameters assessed at 21, 60, & 90 days. Participant compliance with gummy consumption protocol during the study period. Occurrence of any adverse effects or discomfort associated with gummy consumption during the trialTimepoint: After 90 days of trial

Countries

India

Contacts

Public ContactDr Shreya Pokiya

Karnavati school of dentistry

meghapatel@karnavatiuniversity.edu.in9824400464

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026